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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Recall Number Z-1426-2013
Classification Class II
Code Info NA - marketing and promotional only.
Product Distributed Qty 2,423 consignee
Reason For Recall Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

Event Detail

Event Id 65072
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide distribution